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SGLT2 Inhibitors and TZD for Type 2 Diabetes on DPP4 Inhibitors

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What is being tested

Sitagliptin 100 mg

+ Sitagliptin 100 mg + Dapagliflozin 10 mg

+ Sitagliptin 100 mg + Dapagliflozin 10 mg + Lobeglitazone 0.5 mg

Drug
Who is being recruted

Diabetes Mellitus+6

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 19 to 75 Years
+24 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: September 2025
See protocol details

Summary

Principal SponsorYonsei University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2025

Actual date on which the first participant was enrolled.

This clinical trial is designed to explore new ways to improve blood sugar control in people with type 2 diabetes who are already taking a type of medication known as DPP4 inhibitors. The study tests three different strategies: using an SGLT2 inhibitor alone, using a TZD alone, or combining both medications, compared to continuing with just the DPP4 inhibitor. The goal is to see if adding these medications can better manage blood sugar levels, which is crucial for preventing complications of diabetes. This trial is important for adults between 19 and 75 years old with type 2 diabetes who have been on stable diabetes medication. Participants in the study will be randomly placed into one of four groups. Each group will follow a specific medication plan for either 12 or 24 weeks. The main focus is on changes in HbA1c levels, a marker of long-term blood sugar control. Researchers will also look at other factors like fasting and after-meal blood sugar levels, insulin levels, cholesterol, and body composition. The trial is conducted at multiple hospitals in Korea, with all medications provided by the study sponsor. Participants will also receive advice on diet and exercise to support their treatment. Regular safety checks will ensure any side effects are promptly addressed.

Official TitleProspective, Open-label, Randomized, Parallel-group, Multicenter, Investigator, Initiated Phase 4 Clinical Trial to Evaluate the Glycemic Lowering Effects of Adding SGLT2 Inhibitor Monotherapy, TZD Monotherapy, or SGLT2 Inhibitor/TZD Combination Therapy in Patients With Type 2 Diabetes on DPP4 Inhibitors
NCT07108985
Principal SponsorYonsei University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 19 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesHyperglycemiaHyperinsulinismInsulin ResistanceMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

5 inclusion criteria required to participate
Adults aged between 19 and 75 years at the time of providing written informed consent.

Diagnosed with type 2 diabetes mellitus and having an HbA1c level between 7.5% and 11.0%.

Receiving DPP4 inhibitor monotherapy or combination therapy with metformin and/or sulfonylurea for at least 8 weeks without dose adjustment.

Provided written informed consent voluntarily after receiving a full explanation of the study.

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19 exclusion criteria prevent from participating
Patients with diabetes other than type 2 diabetes, including type 1 diabetes or gestational diabetes.

Use of TZD or SGLT2 inhibitors within the past 8 weeks, or history of discontinuation due to serious adverse reactions.

Currently receiving four or more antidiabetic medications.

History of diabetic ketoacidosis (with or without coma) or acute/chronic metabolic acidosis within the past 24 weeks.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Sitagliptin 100 mg

Group II

Experimental
Sitagliptin 100 mg + Dapagliflozin 10 mg

Group III

Experimental
Sitagliptin 100 mg + Lobeglitazone 0.5 mg

Group IV

Experimental
Sitagliptin 100 mg + Dapagliflozin 10 mg + Lobeglitazone 0.5 mg

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea

Seoul, South KoreaOpen Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea in Google Maps
Recruiting soonOne Study Center